Asia is not one market, it is many. We help you prioritise the right countries and guide your medical device registration with NMPA, PMDA, CDSCO, MFDS, HSA and the other regional authorities, including local representation.
Markets We Cover
The authorities, the route and the local presence each market expects from a foreign manufacturer.
NMPA
Class I filing, Class II and III registration with the NMPA, type testing in country and a mandatory local legal agent.
PMDA
Todokede, Ninsho or Shonin depending on class, a MAH or D MAH licence holder and JIS aligned testing evidence.
CDSCO
Import licence under the Medical Device Rules with an authorised Indian agent holding the registration.
MFDS
KGMP certification plus product approval through the MFDS, filed by a licensed Korean importer.
HSA
Listing on the Singapore Medical Device Register with abridged routes for devices already approved in reference markets.
TFDA
QMS documentation and product registration with the TFDA, held by a local licence holder.
MDD
Voluntary listing under the Medical Device Administrative Control System, often a fast first step into the region.
Thai FDA
Notification, licensing or listing by risk class, filed through a Thai licence holder.
Kemenkes
Registration with the Ministry of Health through a local distributor who holds the licence on your behalf.
FDA PH
Certificate of Product Registration or notification following the ASEAN Medical Device Directive structure.
MoH
Classification and circulation registration with the Ministry of Health, supported by a local applicant.
Not sure where to start? Book a free consultation and we will build a market priority list around your device and your budget.
Stay up to date with NMPA, PMDA, CDSCO, MFDS, HSA and the wider ASEAN regulatory landscape.
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